Clinical efficacy of Buzhong Yiqi decoction in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial

X U Xiangru; Zhou Yi; Chen Gang; Lei Ming; Zhang Wen; W U Xinxin; P U Yuting; Chen Caiyu; Sun Yuting; Zhou Shuang; Fang Bangjiang

doi:10.19852/j.cnki.jtcm.20230713.002

Clinical efficacy of Buzhong Yiqi decoction in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial

J Tradit Chin Med. 2023 Oct;43(5):1010-1018. doi: 10.19852/j.cnki.jtcm.20230713.002.

Authors

X U Xiangru¹, Zhou Yi², Chen Gang³, Lei Ming³, Zhang Wen¹, W U Xinxin¹, P U Yuting¹, Chen Caiyu¹, Sun Yuting¹, Zhou Shuang⁴, Fang Bangjiang^{1

5}

Affiliations

¹ Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
² School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
³ Department of Intensive Care Medicine, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai 200137, China.
⁴ Acupuncture and Massage College, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
⁵ 5 Institute of Critical Care, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.

Abstract

Objective: To evaluate the efficacy and safety of Buzhong Yiqi decoction (, BZYQ) in the treatment of hospital-acquired pneumonia (HAP) with multi-drug-resistant bacteria (MDRB).

Methods: This 28-day study was conducted at 5 clinical centers in Shanghai. The eligible patients were randomly assigned (1:1) into the intervention group (BZYQ plus conventional Western Medicine therapy) and control group (conventional Western Medicine therapy). The primary outcomes were the clinical response, clinical pulmonary infection score (CPIS), and microbiologic response. The secondary outcomes were the 28-day all-cause mortality (ACM), Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score, ventilator weaning rate, length of mechanical ventilation (MV), length of hospital stay, and changes of infection indicators.

Results: Altogether 83 subjects in the intervention group and 85 subjects in the control group were analyzed. The clinical success rate (48.2%) and the pathogen eradication rate (59.0%) of the intervention group were all better than those of the control group (32.9% and 38.9%, respectively) with statistically significant differences (<0.05). The CPIS score of the intervention group (8.9 ± 1.7) was lower than that of the control group (9.6 ± 2.5) (<0.05). The length of MV in the intervention group [(13.7 ± 6.4) d] was significantly shorter than that of the control group [ (17.2 ± 7.2) d] (<0.05). The 28-day ACM of the intervention group (13.33%) was lower than that of the control group (21.2%) with no statistically significant difference (>0.05). The differences between two groups in ventilator weaning rate, length of hospital stay, and APACHE Ⅱ score were not statistically significant (> 0.05). The intervention group displayed decreases in white blood cell count, C-reactive protein, neutrophil percentage, and procalcitonin at day 28 compared with baseline (<0.05). No serious adverse events occurred in either group during the 28-day follow-up.

Conclusion: BZYQ may be an effective therapeutic option for the management of HAP with MDRB.

Keywords: Buzhong Yiqi decoction; bacteria; drug resistance, multiple; healthcare-associated pneumonia; randomized controlled trial.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Bacteria* / genetics
China
Hospitals*
Humans
Prospective Studies
Treatment Outcome

Grants and funding

Supported by Basic Research Program of Shanghai Municipal Science and Technology Commission: A Multicenter, Randomized, Controlled Clinical Study on Fuzheng Quxie Jing Prescription "Buzhong Yiqi Decoction" in the Treatment of Hospital-acquired Pneumonia caused by Multi-drug Resistant Bacteria (No. 18401971600) and Three-year Action Plan for the Development of Traditional Chinese Medicine in Shanghai: National TCM Emergency Medical Rescue Base Construction [No. ZY(2021-2023)-0101-01]; East China Area and Municipal TCM Specialty Disease Alliance Construction [No. ZY(2021-2023)-0302]